The Case for Federal Oversight of EHR Vendors to Promote Interoperability and Usability

In 2013, healthcare industry stakeholders, including associations, EHR vendors, practitioners and providers, raised significant concerns relating to the implementation timing of meaningful use Stage 2 and 3 criteria, including problems with interoperability, usability and regulatory failure to assess “value added” by implementation of meaningful use criteria to date. On December 6, 2013, federal officials announced that Centers for Medicare and Medicaid Services (“CMS”) were proposing a new timeline for the implementation of meaningful use stage criteria for the Medicare and Medicaid Electronic Health Record (“EHR”) incentive programs. The Office of the National Coordinator for Health Information Technology (“ONC”) further proposed a more regular approach for the update of ONC’s certification regulations.

Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers had completed at least two years in Stage 2. The goal of the proposed changes is twofold; to allow CMS and ONC to focus efforts on the successful implementation of the enhanced patient engagement, interoperability and health information exchange requirements in Stage 2, as well as evaluate data from Stage 1 and Stage 2 compliance, to date, to create and form policy decisions for Stage 3.

Roy Bossen

CMS expects to release proposed rulemaking for Stage 3 in the fall of 2014, which may further define this proposed new timeline. Stage 3 final rules would follow in the first half of 2015.

Despite CMS’s positive response to stakeholders concerns relating to the timeline for implementation of Stage 2 and Stage 3 meaningful use criteria, significant reservations continue to be enunciated, on a monthly basis, by providers at both Health information technology (“HIT”) policy committee and work group meetings. Providers continue to urge rule makers to institute consensus standards that could be adopted broadly across the healthcare industry to ensure both usability and interoperability.

In early 2013, former national coordinate Farzad Mostashar chastised electronic health record vendors for improper behavior in the marketing and sales of systems that continued to frustrate interoperability goals. This frustration with EHR vendors continues to be enunciated in HIT policy committee and work group meetings as recently as January of 2014.

Linnea Schramm

In a recent HIT policy accountable care work group committee meeting, participants called upon CMS to impose regulations to encourage and/or require EHR vendors to build interoperability into the HIT infrastructure. Presently, more than 700 vendors produce approximately 1,750 distinct certified EHR products. Certification requirements, however, have not been focused on the ultimate goals of Stage 2 meaningful use (i.e., interoperability and usability to promote quality patient care at an affordable cost).

Federal oversight of EHR vendors is largely unregulated. Notwithstanding industry growth, a small number of companies controlling much of the market have frustrated interoperability goals contemplated by Stage 2 criteria. Providers argue that vendors do not have a vested interest to build interoperability into their systems. Many EHR vendors do not meet Stage 2 meaningful use criteria as written and are not motivated to do so. Vendor architectural requirements hamper and constrain their products. To the extent that vendors offer solutions for data sharing, they offer and require all users to be on the same platform or they charge significant fees to interface nonconforming entities. Vendors often refuse to communicate solutions devised for other clients to common problems. Commercial contracts between providers and vendors often prohibit frank discussion about problems with a given system, even in published medical literature. Concern exists that public discussion of problems with EHR may lead to malpractice lawsuits against the healthcare provider and/or product liability lawsuits against vendors. Communications in this regard are not protected against use by the legal community at this time.

Michael Dowell

Creating two-way interfaces between certified EHRs and data warehouses is costly and time consuming. Large organizations, including the EHR vendors, have a market-base incentive to use technology to lock patients into silos.

Providers point out that power dynamics between the vendor and customer, after entering into EHR system contracts, results in the vendor having all the power and none of the responsibility. Agreements tend to come close to contracts of adhesion despite the size of the provider. Vendor agreements for EHR systems lack meaningful warranties. They fail to comment in any way on usability and interoperability. They tend to include unreasonable indemnity provisions. They contain language that makes a later decision to change vendors unduly complicated and costly.

Many have commented that although HIT use has increased the quality and efficiency of patient care it has, at best, improved only marginally. Others have suggested that EHR adoption has resulted in medical errors, causing harm and even death. Worse yet, annual aggregate expenditures on healthcare have increased from approximately $2 trillion dollars in 2005 to $2.8 trillion dollars in 2013; a far cry from the rosy future that HIT supporters promised. EHR safety concerns arising from use of inferior EHR products in the clinical environment include: (a) communication failure; (b) wrong order/wrong patient errors; (c) poor data display; and (d) alert fatigue.

As HIT products become more intimately involved in the coordination and delivery of care, the potential for HIT induced medical errors causing harm or death has increased significantly. Authors have cited dosing errors, delay in diagnosis and delays in treatment issues because of poor human/computer interaction or loss of data as HIT evolves. EHR errors are often attributed to user experience level and training, but may occur because of human errors secondary to poor product design.

Usability concerns include violation of common interface design, heuristic rules such as presenting consistent models of function or usable legible workflow mismatching relating to lack of consistency between provider modeling of work and design models inscribed into EHR. Deficiencies in the IT system designs can inhibit provider discovery of error and efforts to correct such errors.

Fear of rapid obsolescence and uncertainty about the future regulatory environment are cited as reasons for delay in adoption of EHR systems. Providers are reticent to purchase technology to comply with meaningful use requirements that does not allow compliance with Stage 2 goals.

Aggregation of clinical and financial data is important. Without real time reasonably complete information, it is difficult to provide quality care at a reasonable cost. It is difficult to identify high-risk patients and timing intervention in the course of their disease. Interoperability necessarily requires unified metrics, document format and vocabulary are required to make the possible integration of clinical data, communication during transfers of care, billing and documenting meaningful use.

There is little market pressure to force vendors to agree on common data sources and mechanisms of storage. This often results in fragmentation of data, frustrating the goals of the Health Information Technology for Economic and Clinical Health Act (“HITECH”). There are no standards for big data or any requirement for enforcement of standardization that would improve the ability to manage patient populations.

Providers are repeatedly suggesting at various HIT committee meetings that Stage 3 require EHR vendors to provide a standard application program interface (“API”) that enables other health IT programs to extract data from and input data into the EMR. Standard application program interfaces assure interoperability across platforms if properly created and used. API would be published, public and open to any third party vendor. CMS could use EMR certification to enforce the requirements. Federal oversight can help ensure vendor compliance. Financial incentives to vendors should also be considered to promote further vendor participation. Adoption of standardized program interfaces would eliminate financial barriers to data integration. Requiring vendors to share capability regarding API availability with providers would allow for better informed choices by existing providers.

It is clear that vendors alone are not responsible for failure to meet interoperability and usability goals. Competition among providers and lack of proper governance inhibit data and process integration. Market consolidation and leakage, increasing competition for patients also adversely affects the free exchange of information. While industry and regulators continue to confront roadblocks adversely affecting infrastructure evolution, inadequate planning and coordination continue to hamper success. CMS and ONC, through updating of Stage 2 meaningful use criteria and implementation of Stage 3 criteria must speak directly to standardization of HIT infrastructure to promote interoperability, ensure cost efficiencies, improve care and meet the goals enunciated in HITECH.

James Hofert, Partner in the Chicago office of Hinshaw & Culbertson, LLP, is an experienced trial lawyer who has a substantial practice in the areas of complex tort litigation, including insurance bad faith, product liability, hexavalent chrome, silica, asbestos, toxic tort and medical malpractice.

Roy Bossen, Partner in the Chicago office of Hinshaw & Culbertson, LLP, concentrates his practice in corporate health care. He has represented numerous hospitals and physician groups in corporate and regulatory matters.

Linnea Schramm, Associate in the Chicago office of Hinshaw & Culbertson, is a trial lawyer who concentrates her practice in the areas of medical malpractice defense litigation and healthcare law.